Project Summary and Abstract The College of Pharmacy (COP) Infectious Disease Pharmacokinetics Laboratory (IDPL) at the University of Florida (UF) has vast experience in developing, validating and performing bioanalytical assays. The lab is CLIA licensed, and College of American Pathologists (CAP) inspected and certified biannually. The lab also follows CFR Part 58 (Good Laboratory Practice for Nonclinical laboratory studies) and follows relevant FDA Guidances for Industry (e.g. the newest Bioanalytical assay validation guidance) for work requiring that degree of compliance. The lab has provided analytical work for Industry and FDA that conforms to standards acceptable for regulatory submission. The IDPL is set up with state of the art equipment and data management systems, as well as SOPs, outlining procedures for accepting and repeating analytical runs or samples. The IDPL has considerable experience in preparing analytical and pharmacokinetic reports. This includes assay reports, as well as non-compartmental, compartment analysis, and population pharmacokinetic analysis. Charles Peloquin, Pharm.D. provides expertise in analytical and pharmacokinetic evaluation of drug action. The IDPL, during its 27 years of existence, has substantial experience in providing results of assay development and validation to sponsors. This includes submission of raw data, assay validation results and validation protocols and reports. Assay development and validation, as well as data transfer will be performed according to relevant FDA Draft Guidance for Industry. [1-3] For this project, the IDPL will develop all of the necessary assays and validate them in several matricies, including hollow fiber system (HFS) broth, animal plasma, and animal BAL fluid in support of the experiments described in other sections. The IDPL will communicate these results on a timely basis to the other Cores involved in the project.